Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children

Part of paid clinical trials in Livingston, New Jersey.

Sponsor
Rutgers, The State University of New Jersey
Study ID
NCT07188779
Phase
PHASE2
Status
Recruiting
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Conditions

  • Postoperative Pain

Eligibility Criteria

Sex
ALL
Age
3 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • RADA16 hydrogel — DEVICE
    Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.

Study Details

The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following pediatric tonsillectomy procedures. Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.Participants will: Undergo tonsillectomy procedure. Receive and fill out a survey sent via email every 2 days following their procedure for 15 days, plus an additional survey on day 30, and track their symptoms.

Key Dates

Start date
Jul 1, 2026
Status verified
Jun 2026
Primary completion
Dec 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
134 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: RADA16
    Patients randomized to the treatment arm will undergo application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.
  • No Intervention: Control arm
    Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.

Primary Outcome Measure

Postoperative pain [ Time Frame: From enrollment to post-operative day 30. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Cooperman Barnabas Medical CenterLivingstonNew Jersey07039
Wayne D Hsueh, MD
[email protected]
9739722548
Wayne Hsueh, MD (PRINCIPAL_INVESTIGATOR)
University HospitalNewarkNew Jersey07103
Wayne D Hsueh, MD
[email protected]
9739722548
Wayne Hsueh, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Cooperman Barnabas Medical Center· Livingston, NJUniversity Hospital· Newark, NJ

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